Ribitol clinical trials
Ribitol is named as an intervention in 3 current clinical trials in our USA, UK, Germany, Italy, Netherlands, Denmark, Norway and Australia registers. None are recruiting at the moment. The most common phase is Phase 3. The lead sponsor is ML Bio Solutions, Inc. The most-studied condition is Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I). The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Ribitol is approved
All regulators →- 1 EU orphan designation, most recently for treatment of limb-girdle muscular dystrophy (19 Oct 2020, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Ribitol works
All drug targets →- Limb-girdle muscular dystrophyPhase 3
- Autosomal recessive limb-girdle muscular dystrophy type 2IPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3137744, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Ribitol
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Ribitol
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)
NCT05775848 · Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
|
Phase 3 | Active, closed | ML Bio Solutions, Inc | UK, USA, Germany, Italy, Netherlands, Denmark, Norway, Australia |
|
Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9
NCT07678775 · Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
|
Phase 3 | Active, closed | ML Bio Solutions, Inc | UK, USA, Germany, Italy, Netherlands, Denmark, Norway, Australia |
|
Study of BBP-418 in Patients With LGMD2I
NCT04800874 · LGMD2I
|
Phase 2 | Active, closed | ML Bio Solutions, Inc | USA |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ribitol in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ribitol. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of BBP-418 (Ribitol) in Participants with Limb-Girdle Muscular Dystrophy 2I/R9 (LGMD2I/R9)
2025-524371-23-00 · Musculoskeletal Diseases
|
Phase 3 | Authorised | ML Bio Solutions Inc | Germany, Denmark, Netherlands + 2 more |
Conditions studied with Ribitol
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| ML Bio Solutions, Inc | 3 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Questions about Ribitol trials
How many clinical trials are testing Ribitol?
3 current trials in our USA, UK, Germany, Italy, Netherlands, Denmark, Norway and Australia registers name Ribitol (also registered as BBP-418) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Ribitol trials recruiting patients?
Not at the moment. None of the 3 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.
Who sponsors Ribitol clinical trials?
The lead sponsor is ML Bio Solutions, Inc. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ribitol works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ribitol works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ribitol (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.